SPL v1
SPL
SPL Set ID 44763bf6-caf3-ec69-e063-6394a90a0ee1
Route
DENTAL
Published
Effective Date 2025-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.05 g)
Inactive Ingredients
Sodium Benzoate Propolis Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-01

Description

Sodium fluoride 0.05% (Total Fluoride Content 277 ppm Approx.)

Purpose

Anticavity mouthwash


Medication Information

Purpose

Anticavity mouthwash

Description

Sodium fluoride 0.05% (Total Fluoride Content 277 ppm Approx.)

Uses

■ Aids in prevention of dental cavities

Section 51945-4

Warnings

■ Stop using this product and consult a dentist if irritation occurs.

■ For children under 6 years of age, use only a small amount under adult supervision to prevent sucking or swallowing.

■ If a child under 6 swallows a large amount, seek medical help or consult a dentist immediately.

■ Keep out of reach of children under 6 years of age.

Questions

■ https://docsmedi.kr

■ Tel: 82-031-922-2240, Fax: 82-031-365-4596

Directions

■ Rinse mouth with this COOLSENSE GARGLE about 10~15ml for 60 seconds then expel

Active Ingredient

Sodium fluoride 0.05%

(Total Fluoride Content 277 ppm Approx.)

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

Inactive Ingredients

Sodium benzoate, Propolis extract, Turmeric root extract, Xylitol, GrapefruitSeed extract, Aloe extract(09), Matricaria extract, rosemary extract, Green tea extract, Mulberry Root extract, Peppermint oil, L-menthol, Naturalaromatics, Steviol glycoside, Concentrated glycerin, Polyoxyethylene hydrogenated caster oil, Poloxamer 407, Purified water

Keep Out of Reach of Children

■ Keep out of the reach of children under 6 years of age.


Structured Label Content

Uses

■ Aids in prevention of dental cavities

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Anticavity mouthwash

Warnings (WARNINGS)

■ Stop using this product and consult a dentist if irritation occurs.

■ For children under 6 years of age, use only a small amount under adult supervision to prevent sucking or swallowing.

■ If a child under 6 swallows a large amount, seek medical help or consult a dentist immediately.

■ Keep out of reach of children under 6 years of age.

Questions

■ https://docsmedi.kr

■ Tel: 82-031-922-2240, Fax: 82-031-365-4596

Directions

■ Rinse mouth with this COOLSENSE GARGLE about 10~15ml for 60 seconds then expel

Active Ingredient (ACTIVE INGREDIENT)

Sodium fluoride 0.05%

(Total Fluoride Content 277 ppm Approx.)

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

Inactive Ingredients (Inactive ingredients)

Sodium benzoate, Propolis extract, Turmeric root extract, Xylitol, GrapefruitSeed extract, Aloe extract(09), Matricaria extract, rosemary extract, Green tea extract, Mulberry Root extract, Peppermint oil, L-menthol, Naturalaromatics, Steviol glycoside, Concentrated glycerin, Polyoxyethylene hydrogenated caster oil, Poloxamer 407, Purified water

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

■ Keep out of the reach of children under 6 years of age.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)